Roche Receives FDA Approval for Hepatitis C Viral Load Test on Its …
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PLEASANTON, Calif., Oct. 30 /PRNewswire/ — Roche Molecular Diagnostics today announced that the U.S. Food & Drug Administration (FDA) has approved the COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HCV Test for use in the United States. The test uses Roche’s proprietary real-time PCR technology to quantify the amount of Hepatitis C RNA in a patient’s blood. Physicians use Hepatitis C viral load testing results to establish a baseline raze of hepatitis C infection and to serially overseer viral load levels and usage effectiveness in patients on therapy.
